Resources
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629 result(s) found, displaying 76 to 100
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/BWP/457920/2012 rev 1
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/BWP/247713/2012
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FormsUpdated form used to notify us of proprietary ingredient mixtures for use in therapeutic goods.
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/311805/2014.
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FormsUse this form to request reinstatement of a cancelled entry on the Australian Register of Therapeutic Goods.
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FormsUse this form to apply for an Australian Approved Name (AAN).
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FormsForm to notify the TGA of the Exceptional Release of a non-conforming biological.
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User guideThis user guide outlines how to communicate effectively with consumers using the revised Consumer Medicine Information (CMI) template
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International scientific guidelines adopted in AustraliaInternational scientific guideline - (CPMP/QWP/2819/00) EMEA/CVMP/814/00
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FormsRequest cancellation of a therapeutic good on the Australian Register of Therapeutic Goods (ARTG).
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/488220/2012.
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FormsApply to import and supply substitute medicines under section 19A
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ChecklistsThis checklist can help you assess if your advertising complies with legislative requirements.
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User guideStep by step user guide on submitting applications to register a complementary medicine or over the counter (OTC) medicine in the Australian Register of Therapeutic Goods, using the TGA Business services.
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FormsSubmission dossier checklist for prescription medicines
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - ICH E6(R3) Guideline for Good Clinical Practice
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International scientific guidelines adopted in AustraliaInternational Scientific Guideline - (CPMP/QWP/2820/00) EMEA/CVMP/815/00
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FormsComplete this form to authorise or remove an agent (e.g. a regulatory affairs consultant) or people external to your company to undertake regulatory correspondence with us.
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User guideWe have made templates for Product Information (PI) and Consumer Medicine Information (CMI) documents to assist sponsors lodging variation applications for solid-dose single ingredient paracetamol products affected by scheduling changes.
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User guideElectronic data interchange for ICSR submission using the E2B R2 format
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/QWP/BWP/259165/2019
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User guideThis user guide will assist you in providing the required information for completing (and submitting) an application for an assessed listed medicine (either for new ARTG entries or changes to existing ARTG entries)
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FormsThis form is used to nominate a new representative from your organisation to be the administrator
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International scientific guidelines adopted in AustraliaWe have adopted this International Scientific Guideline - EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1